Clinical trial Recruiting at 1 site Observational Ages 18 to 79

Neoadjuvant immunotherapy before surgery for non-small cell lung cancer

Official title: Effects of Neoadjuvant Immunotherapy on Patients With Lung Cancer: a Prospective, Observational Study

Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT07166003 · Data updated 2026-11-12

This project will see if giving immunotherapy before surgery helps adults with non‑small cell lung cancer and whether pneumonectomy, lobectomy, or non‑surgical treatments lead to better long‑term outcomes.

Quick facts

Study typeObservational
Ages18 Years to 79 Years
SexAll
Enrollment500 (estimated)
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Beijing)
StatusRecruiting
StartedApril 20, 2025
Main results expectedFebruary 2, 2027
Study endsApril 14, 2030
Registry record updatedSeptember 10, 2025
Trial IDNCT07166003 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–79 with non‑small cell lung cancer who have received at least two cycles of neoadjuvant immunotherapy, have ECOG 0, and have complete clinical and imaging data are the ideal candidates.

Probably not a fit

People with active autoimmune disease, EGFR/ALK‑sensitive mutations, prior chemotherapy or radiotherapy, organ transplantation, severe lung disease, uncontrolled diabetes or hypertension, or who are pregnant or breastfeeding are unlikely to be included and may not benefit from the study's findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows adults with non‑small cell lung cancer who receive at least two cycles of neoadjuvant immunotherapy and records their subsequent treatments and outcomes. Participants undergo different post‑immunotherapy management—pneumonectomy, lobectomy, or radiotherapy—and investigators will compare long‑term clinical outcomes such as survival, recurrence, and lung function. Eligibility is limited to patients aged 18–79 with ECOG 0 and complete clinical and imaging data, while those with active autoimmune disease, EGFR/ALK‑sensitive mutations, prior anti‑tumor therapy, or severe comorbidities are excluded. The study uses routine clinical data and longitudinal follow‑up to identify differences between surgical approaches and between surgical and non‑surgical modalities after neoadjuvant immunotherapy.

Why it matters

Potential benefit: If successful, the results could help doctors choose the best surgical approach or decide between surgery and non‑surgical options after neoadjuvant immunotherapy, potentially improving survival and quality of life.

How similar studies have gone: Prior neoadjuvant immunotherapy trials in NSCLC have shown encouraging tumor responses and pathologic downstaging, but head‑to‑head observational comparisons of pneumonectomy versus lobectomy or surgery versus radiotherapy after such therapy remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Aged between 18 and 79 years;
2. Received at least two cycles of neoadjuvant immunotherapy;
3. ECOG performance status score of 0;
4. Complete clinical information including imaging data available.

Exclusion Criteria:

1. Diagnosed with or suspected active autoimmune diseases;
2. Presence of EGFR/ALK sensitive mutations;
3. Pregnant or breastfeeding women;
4. Previous anti-tumor therapies including chemotherapy or radiotherapy;
5. History of organ transplantation or hematopoietic stem cell transplantation;
6. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema;
7. Uncontrolled diabetes mellitus;
8. Uncontrolled hypertension.

Where it's running

  • Cancer Hospital Chinese Academy of Medical Sciences
    Beijing, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.